Use of Insorb Absorbable Vicryl Staples in Skin Closure for Cesarean Section

May 2, 2013 updated by: Jonathan P Faro, The University of Texas Health Science Center, Houston

Comparison of Vicryl Absorbable Sutures and Metal Staples Used in Skin Closure Following Cesarean Section

The purpose of this study is to evaluate the incidence of wound breakdown or wound infection following skin closure with Insorb subcuticular absorbable staples versus metal staples after cesarean section through a retrospective chart analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Procedures:

A list will be compiled of patients who underwent cesarean section at Memorial Hermann Hospital in the Texas Medical Center from January 1st 2010 through January 1st 2011. Only UT patients who had their skin closed with Insorb or metal staples will be included in this list. Patients' clinical charts will be reviewed for post-operative follow-up, and notes will be made of the wound assessment. Any complications such as infection, seroma, hematoma, and wound separation or delayed healing will be recorded. Additional notes will be made of any co-morbid conditions, including, but not limited to, >30 BMI, chronic hypertension, diabetes mellitus, HIV, history of tobacco use.

Once the data is gathered, it will be compared with published national averages to determine if there is an increased risk of wound separation or wound infection at our institution. In addition, rated of infection and wound breakdown following closure with either absorbable or metal staples will be compared by Fisher's exact test, to determine statistical significance.

Course of Study: Data will be obtained from UT patients who underwent cesarean section from January 1st, 2010 through January 1st, 2011. Only patients who had skin closure with InSorb or metal staples will be included in analysis.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women undergoing cesarean section who have their skin incision closed with staples.

Description

Inclusion Criteria:

  • Cesarean sections
  • UT patients

Exclusion Criteria:

  • Patients who have skin closed with suture, per attending choice.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
metal staples
Other: There is no intervention for this study
None, no intervention made.
Other Names:
  • This is an observational study, involving human subjects. It is a clinical study, but not a clinical trial. No intervention will be made.
Insorb vicryl staples
Other: There is no intervention for this study
None, no intervention made.
Other Names:
  • This is an observational study, involving human subjects. It is a clinical study, but not a clinical trial. No intervention will be made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wound infection/separation
Time Frame: from time of surgery up until wound assessed to be completely healed, no longer than 1 year.
from time of surgery up until wound assessed to be completely healed, no longer than 1 year.

Secondary Outcome Measures

Outcome Measure
Time Frame
wound hematoma
Time Frame: From time of surgery up until wound assessed to be completely healed, no longer than 1 year.
From time of surgery up until wound assessed to be completely healed, no longer than 1 year.
wound seroma
Time Frame: From time of surgery up until wound assessed to be completely healed, no longer than 1 year.
From time of surgery up until wound assessed to be completely healed, no longer than 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Jonathan P Faro, MD, PhD, UTHSC at Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 30, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimate)

October 5, 2011

Study Record Updates

Last Update Posted (Estimate)

May 3, 2013

Last Update Submitted That Met QC Criteria

May 2, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-GEN-11-0169

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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